EP 1 343 693 B1 discloses a device for producing and filling containers such as ampules, with at least one mold having movable mold walls and receiving at least one extruded tube of plasticized plastic material. The mold parts can be closed to weld the leading end of the tube to form a container bottom by welding edges located on the mold parts. A device for producing a pressure gradient acts on the tube and widens it for forcing the container on the mold walls. A movable separating element can be moved to form a fill opening by cutting the tube above the mold between a withdrawn base position and a working position. A transfer device moves the mold into a filling position for filling the container through the fill opening. A sterile barrier is provided in a positional arrangement and with dimensions such that it is located in the working position of the separating element above the path of motion of the mold leading into the fill position. The sterile barrier is a plate heated to a germ-killing temperature and can be moved together with a blade which used as a separating element. This European patent also discloses a production method for these containers using the device.
When highly sensitive products are produced, for example in the form of special pharmaceuticals requiring satisfaction of international standards for aseptic packaging, the mold, when moved into the filling position, is located under a sterile filling chamber (ASR) in which sterile air flows over the open fill opening of the container and forms effective protection against the penetration of germs until after completion of the filling process and the movable head jaws of the mold are closed to form the head closure of the container by a combined vacuum welding process. The sterile barrier prevents foreign bodies from being able to fall into the open fill opening after the tube is severed and before the mold has reached the sterile filling chamber (ASR). During this segment of the process, the sterile barrier also prevents objectionable influx of germs into the fill opening.
Oxygen-sensitive products including high quality pharmaceuticals added to the container, such as ampules, then come into contact with residual oxygen content in the container leading to damage, especially in the form of oxidation on the added product. This exposure is accompanied by a distinct reduction of possible storage life. Accordingly, for sensitive products a remaining portion of oxygen in the head space of the container kept free of the added product of less than 0.5%, preferably of less than 0.2%, is currently required. These requirements are not adequately satisfied either by the sterile barrier device or other known production methods together with devices as are shown, for example, by U.S. Pat. No. 5,961,039 or JP-A-4147824.
This disadvantage ultimately also applies to devices minimizing the oxygen content for containers to be filled, such as ampules, with a displacement medium supplied by a supply device to displace the oxygen from the container before it is sealed. Thus JP 2004-042961 AA discloses a device in which a supply device moved over the free container opening of a filled container blows inert gas as a displacement medium in the direction of the container to reduce the oxygen content by displacement out of the container opening.
DE 1 566 547 A discloses a process for filling and sealing ampules as containers. A filling mandrel with a filling channel supplies the product to be placed in the container and is encompassed in a concentric arrangement by a medium supply channel surrounded to the outside by one wall part of the supply device. The medium supply channel supplies a displacement medium in the form of an inert gas to minimize the oxygen content within the container.
U.S. Pat. No. 6,112,780 discloses a generic device for minimizing the oxygen content for containers to be filled, such as bottle products, with a supply device having different medium transport channels in a concentric arrangement. The innermost channel forms the filling channel of a filling mandrel. A medium supply channel encompasses the filling channel for removing the displacement medium in the form of an inert gas and is in turn surrounded by a medium drain channel for removing the displacement medium together with the oxygen from the container (3-tube solution). In one especially preferred embodiment of the known device for minimizing the oxygen content, another medium supply channel in a concentric arrangement between the first medium supply channel and the outermost medium drain channel moves the displacement medium pulsed into the interior of the container with the added product (4-tube design). In another alternative configuration of the known solution, space permitting, in the container, the indicated medium channels can be provided separated from one another and next to one another in a line within the device. The minimization device is geometrically large in each version of the solution in the area of medium supply leading to large volumes of oxygen to be displaced. This known solution is not suitable either for producing the required setpoints of 0.2 to 0.5% residual oxygen content in the free head area of the container.